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AVJ-514 Japan Trial

Primary Purpose

Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
AVJ-514
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Stenosis With Insufficiency focused on measuring Mitral Regurgitation, mitral valve surgery, AVJ-514 Delivery System, Symptomatic Heart Failure, Heart Valve Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria:

  1. Age 20 years or older.
  2. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
  3. Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
  4. New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.

  5. Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:

    • Porcelain aorta or mobile ascending aortic atheroma
    • Post-radiation mediastinum
    • Previous mediastinitis
    • Functional MR with LVEF < 40%
    • Over 75 years old with LVEF < 40%
    • Re-operation with patent grafts
    • Two or more prior cardiothoracic surgeries
    • Hepatic cirrhosis
    • Other surgical risk factor(s)
  6. Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE.
  7. Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration.
  8. The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-514. If a secondary jet exists, it must be considered clinically insignificant.
  9. Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician.
  10. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site.

Exclusion Criteria:

Subjects must not meet any of the following exclusion criteria:

  1. LVEF is < 30%

  2. Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes:

    • Insufficient mobile leaflet available for grasping with the AVJ-514 device
    • Lack of both primary and secondary chordal support in the grasping area
    • Evidence of significant calcification in the grasping area
    • Presence of a significant cleft in the grasping area
  3. Life expectancy < 1 year due to associated non-cardiac co-morbid conditions
  4. Need for emergent or urgent surgery for any reason
  5. Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure.
  6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  7. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
  8. Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration.
  9. Cerebrovascular accident within 180 days prior to registration
  10. Severe symptomatic carotid stenosis (> 70% by ultrasound)
  11. Any cardiac surgery within 180 days prior to registration
  12. Percutaneous coronary intervention (PCI) within the last 30 days prior to registration
  13. Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD)within the last 30 days prior to registration.
  14. Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration.
  15. Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment.
  16. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT).
  17. Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump.
  18. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
  19. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment.
  20. Intravenous drug abuse or suspected inability to adhere to follow-up.
  21. Patients in whom TEE is contraindicated.
  22. A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically.
  23. In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads.
  24. Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure.
  25. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
  26. In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  27. In the opinion of the anesthesiologist, general anesthesia is contraindicated.
  28. Pregnant or planning pregnancy within next 1 year.

Sites / Locations

  • Shonan Kamakura General Hospital
  • Sendai Kosei Hospital
  • National Cerebral and Cardiovascular Center
  • Keio University Hospital
  • Sakakibara Heart Institute
  • Tokyo Women's Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AVJ-514

Arm Description

The AVJ-514 system

Outcomes

Primary Outcome Measures

Number of Participants With Acute Procedure Success (APS)
APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.

Secondary Outcome Measures

Percentage of Participants With Major Adverse Events (MAE) at 30 Days
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Percentage of Participants With MAE at 1 Year
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access
MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: Death Stroke Myocardial infarction Renal failure Non-elective cardiovascular surgery for device or procedure related adverse events
Number of Participants With Mitral Valve Stenosis Requiring Surgery
Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.
Number of Participants With Mitral Valve Stenosis Not Requiring Surgery
Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.
Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Number of Participants With Iatrogenic Atrial Septal Defect
Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.
Percentage of Participants With Device Implant Rate
Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.
Device Procedure Time
Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Total Procedure Time
Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.
Device Time
Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.
Fluoroscopy Duration
Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.
Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)
Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)
Length of Hospital Stay Excluding Rehabilitation Stay
Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)
Length of Rehabilitation Stay
Cumulative days of rehabilitation stay during hospitalization.
Percentage of Participants With Discharge Status
Location to which subject was discharged (home or another facility).
Length of Stay (Not at Baseline Facility)
If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.
Number of Participants With Mitral Regurgitation (MR) Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Number of Participants With MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
MR Severity Grade
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
MR Severity Grade
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Regurgitant Volume (RV)
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site
Left Ventricular End Diastolic Dimension (LVEDD)
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Left Ventricular End Systolic Dimension (LVESD)
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Left Ventricular Ejection Fraction (LVEF)
Left Ventricular Ejection Fraction (LVEF)
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Pulmonary Artery Systolic Pressure (PASP)
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Mitral Valve Area (MVA)
It is the orifice area of the mitral valve.
Mitral Valve Area(MVA)
It is the orifice area of the mitral valve.
Mitral Valve Area(MVA)
It is the orifice area of the mitral valve.
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve.
Mitral Valve Area (MVA)
It is the orifice area of the Mitral Valve.
Mitral Valve Area (MVA)
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Mean Mitral Valve Pressure Gradient (MVG)
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Mean Mitral Valve Pressure Gradient (MVG)
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Forward Stroke Volume (FSV)
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Forward Stroke Volume (FSV)
Forward Stroke Volume (FSV)
Forward Stroke Volume (FSV)
Forward Stroke Volume (FSV)
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Cardiac Output (CO)
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Cardiac Index (CI)
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Cardiac Index (CI)
Number of Participants With All-cause Mortality
All-cause Mortality
All-cause Mortality
All-cause Mortality
All-cause Mortality
Number of Participants With the Primary Safety Composite of MAE at 1 Year
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Freedom From the Components of the Primary Safety Composite of MAE
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Number of Patients With New York Heart Association (NYHA) Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Number of Participants With NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
NYHA Functional Class
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Change in KCCQ QoL Scores From Baseline to 1 Year
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
SF-36 QoL Scores
The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for congestive heart failure (CHF) population are 31 & 46, respectively.
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in SF-36 QoL Scores From Baseline to 1 Year
SF-36 QoL Scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change in SF-36 QoL Scores From Baseline
Number of Participants Undergoing Mitral Valve Surgery
Number of Participants With Additional Mitra Clip Device Intervention
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Changes in Six Minute Walk Test (6MWT) Distance From Baseline
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Six Minute Walk Test (6MWT) Distance
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Number of Participants With Mitral Valve Surgery
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Number of Participants With Mitral Valve Surgery
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Number of Participants With Additional AVJ-514 Device Intervention
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Number of Participants With Additional AVJ-514 Device Intervention
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Number of Hospitalizations and Reason for Hospitalization
Number of Hospitalizations
Number of Hospitalizations
Number of Hospitalizations
Number of Hospitalizations
Number of Participants With Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Mitral Stenosis
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Clinically Significant ASD That Requires Intervention
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Number of Participants With Major Bleeding
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Number of Participants With Major Bleeding
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Number of Participants With Usage of Concomitant Cardiac Medications
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior
Number of Participants With Device Embolization Requiring Surgery
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Number of Participants With Device Embolization Not Requiring Surgery
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Regurgitant Fraction (RF)
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.

Full Information

First Posted
July 17, 2015
Last Updated
June 7, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02520310
Brief Title
AVJ-514 Japan Trial
Official Title
A Prospective, Multi-Center, Single-Arm Clinical Evaluation of the AVJ-514 System for the Treatment of Symptomatic Chronic Severe Mitral Regurgitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the study is to confirm the reproducibility of the evidence of safety and efficacy of AVJ-514 System technology in Japanese subjects who have been deemed difficult for mitral valve surgery by the local site heart team.
Detailed Description
This study is a prospective, multi-center, single-arm clinical evaluation of the AVJ-514 System for the treatment of symptomatic chronic severe mitral regurgitation (MR) in Japanese subjects deemed difficult for mitral valve surgery by the local site heart team. Patients will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years in Japanese Medical Centers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Stenosis With Insufficiency, Functional Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
Keywords
Mitral Regurgitation, mitral valve surgery, AVJ-514 Delivery System, Symptomatic Heart Failure, Heart Valve Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVJ-514
Arm Type
Experimental
Arm Description
The AVJ-514 system
Intervention Type
Device
Intervention Name(s)
AVJ-514
Intervention Description
Patients receiving AVJ-514 device
Primary Outcome Measure Information:
Title
Number of Participants With Acute Procedure Success (APS)
Description
APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.
Time Frame
On day 0 (the day of procedure)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Major Adverse Events (MAE) at 30 Days
Description
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Time Frame
30 days
Title
Percentage of Participants With MAE at 1 Year
Description
MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).
Time Frame
1 year
Title
Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access
Description
MAE listed below will be adjudicated by the Clinical Events Committee at 30 days: Death Stroke Myocardial infarction Renal failure Non-elective cardiovascular surgery for device or procedure related adverse events
Time Frame
30 days
Title
Number of Participants With Mitral Valve Stenosis Requiring Surgery
Description
Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.
Time Frame
1 year
Title
Number of Participants With Mitral Valve Stenosis Not Requiring Surgery
Description
Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.
Time Frame
1 year
Title
Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery
Description
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Time Frame
1 year
Title
Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery
Description
SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.
Time Frame
1 year
Title
Number of Participants With Iatrogenic Atrial Septal Defect
Description
Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.
Time Frame
30 days
Title
Percentage of Participants With Device Implant Rate
Description
Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.
Time Frame
On the day of procedure
Title
Device Procedure Time
Description
Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Time Frame
On the day of procedure
Title
Total Procedure Time
Description
Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.
Time Frame
On the day of procedure
Title
Device Time
Description
Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.
Time Frame
On the day of procedure
Title
Fluoroscopy Duration
Description
Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.
Time Frame
On the day of procedure
Title
Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)
Description
Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Length of Hospital Stay Excluding Rehabilitation Stay
Description
Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Length of Rehabilitation Stay
Description
Cumulative days of rehabilitation stay during hospitalization.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Percentage of Participants With Discharge Status
Description
Location to which subject was discharged (home or another facility).
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Length of Stay (Not at Baseline Facility)
Description
If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Number of Participants With Mitral Regurgitation (MR) Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Number of Participants With MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Number of Participants With MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
30 days
Title
Number of Participants With MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
6 months
Title
Number of Participants With MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
1 year
Title
MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
24 months
Title
MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
3 years
Title
MR Severity Grade
Description
Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time Frame
4 years
Title
MR Severity Grade
Time Frame
5 years
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
30 days
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
6 months
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
1 year
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
24 months
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
3 years
Title
Regurgitant Volume (RV)
Description
Regurgitant volume as determined by the site. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time Frame
4 years
Title
Regurgitant Volume (RV)
Time Frame
5 years
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
30 days
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
6 months
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
1 year
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
30 days
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
6 months
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
1 year
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
24 months
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
3 years
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular End Diastolic Volume (LVEDV) as measured by the site. Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Time Frame
4 years
Title
Left Ventricular End Diastolic Volume (LVEDV)
Time Frame
5 years
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
30 days
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
6 months
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
1 year
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
24 months
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
3 years
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular End Systolic Volume (LVESV) as measured by the site. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Time Frame
4 years
Title
Left Ventricular End Systolic Volume (LVESV)
Time Frame
5 years
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
30 days
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
6 months
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
1 year
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Time Frame
24 months
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site.
Time Frame
3 years
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left Ventricular End Diastolic Dimension (LVEDD) as measured by the site
Time Frame
4 years
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Time Frame
5 years
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time Frame
30 days
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time Frame
6 months
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.
Time Frame
1 year
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time Frame
24 months
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time Frame
3 years
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left Ventricular End Systolic Dimension (LVESD) as measured by the site.
Time Frame
4 years
Title
Left Ventricular End Systolic Dimension (LVESD)
Time Frame
5 years
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time Frame
30 days
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time Frame
6 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.
Time Frame
1 year
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Time Frame
24 months
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left Ventricular Ejection Fraction (LVEF) as measured by the site.
Time Frame
3 years
Title
Left Ventricular Ejection Fraction (LVEF)
Time Frame
4 years
Title
Left Ventricular Ejection Fraction (LVEF)
Time Frame
5 years
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
30 days
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
6 months
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
1 year
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
24 months
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
3 years
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
4 years
Title
Pulmonary Artery Systolic Pressure (PASP)
Description
Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.
Time Frame
5 years
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the mitral valve.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the mitral valve.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the mitral valve.
Time Frame
30 days
Title
Mitral Valve Area(MVA)
Description
It is the orifice area of the mitral valve.
Time Frame
6 months
Title
Mitral Valve Area(MVA)
Description
It is the orifice area of the mitral valve.
Time Frame
1 year
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the Mitral Valve
Time Frame
24 months
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the Mitral Valve.
Time Frame
3 years
Title
Mitral Valve Area (MVA)
Description
It is the orifice area of the Mitral Valve.
Time Frame
4 years
Title
Mitral Valve Area (MVA)
Time Frame
5 years
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
30 days
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
6 months
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).
Time Frame
1 year
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time Frame
24 months
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time Frame
3 years
Title
Mean Mitral Valve Pressure Gradient (MVG)
Description
Defined as the mean and peak pressure gradients across the mitral valve as measured by the site.
Time Frame
4 years
Title
Mean Mitral Valve Pressure Gradient (MVG)
Time Frame
5 years
Title
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time Frame
30 days
Title
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time Frame
6 months
Title
Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL
Time Frame
1 year
Title
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time Frame
24 months
Title
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time Frame
3 years
Title
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Description
Systolic Anterior Motion (SAM) of the mitral valve is measured by the site.
Time Frame
4 years
Title
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time Frame
5 years
Title
Forward Stroke Volume (FSV)
Description
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Forward Stroke Volume (FSV)
Description
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Forward Stroke Volume (FSV)
Description
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time Frame
30 days
Title
Forward Stroke Volume (FSV)
Description
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time Frame
6 months
Title
Forward Stroke Volume (FSV)
Description
Defined as the volume of blood pumped from the left ventricle per heartbeat.
Time Frame
1 year
Title
Forward Stroke Volume (FSV)
Time Frame
24 months
Title
Forward Stroke Volume (FSV)
Time Frame
3 years
Title
Forward Stroke Volume (FSV)
Time Frame
4 years
Title
Forward Stroke Volume (FSV)
Time Frame
5 years
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
30 days
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
6 months
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
1 year
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
24 months
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
3 years
Title
Cardiac Output (CO)
Description
Cardiac output as measured by the site. Cardiac output is the product of forward stroke volume and heart rate.
Time Frame
4 years
Title
Cardiac Output (CO)
Time Frame
5 years
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time Frame
At Discharge (≤ 14.4 ± 8.5 days post index procedure)
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time Frame
30 days
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time Frame
6 months
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).
Time Frame
1 year
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time Frame
24 months
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time Frame
3 years
Title
Cardiac Index (CI)
Description
Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the site.
Time Frame
4 years
Title
Cardiac Index (CI)
Time Frame
5 years
Title
Number of Participants With All-cause Mortality
Time Frame
1 year
Title
All-cause Mortality
Time Frame
24 months
Title
All-cause Mortality
Time Frame
3 years
Title
All-cause Mortality
Time Frame
4 years
Title
All-cause Mortality
Time Frame
5 years
Title
Number of Participants With the Primary Safety Composite of MAE at 1 Year
Description
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.
Time Frame
12 months
Title
Freedom From the Components of the Primary Safety Composite of MAE
Description
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time Frame
24 months
Title
Freedom From the Components of the Primary Safety Composite of MAE
Description
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time Frame
3 years
Title
Freedom From the Components of the Primary Safety Composite of MAE
Description
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time Frame
4 years
Title
Freedom From the Components of the Primary Safety Composite of MAE
Description
MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.
Time Frame
5 years
Title
Number of Patients With New York Heart Association (NYHA) Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Number of Participants With NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
30 days
Title
Number of Participants With NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
6 months
Title
Number of Participants With NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
1 year
Title
NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
24 months
Title
NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
3 years
Title
NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
4 years
Title
NYHA Functional Class
Description
Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time Frame
5 years
Title
Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
KCCQ QoL Scores
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
30 days
Title
KCCQ QoL Scores
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
6 months
Title
KCCQ QoL Scores
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
1 year
Title
Change in KCCQ QoL Scores From Baseline to 1 Year
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
Baseline to 1 Year
Title
KCCQ QoL Scores
Description
KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time Frame
24 months
Title
KCCQ QoL Scores
Description
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time Frame
3 years
Title
KCCQ QoL Scores
Description
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time Frame
4 years
Title
KCCQ QoL Scores
Description
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.
Time Frame
5 years
Title
SF-36 QoL Scores
Description
The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for congestive heart failure (CHF) population are 31 & 46, respectively.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
SF-36 QoL Scores
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time Frame
30 days
Title
SF-36 QoL Scores
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
6 months
Title
SF-36 QoL Scores
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
1 year
Title
Change in SF-36 QoL Scores From Baseline to 1 Year
Time Frame
From baseline to 1 year
Title
SF-36 QoL Scores
Description
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
24 months
Title
Change in SF-36 QoL Scores From Baseline
Time Frame
At 24 months
Title
Number of Participants Undergoing Mitral Valve Surgery
Time Frame
Through 5 years
Title
Number of Participants With Additional Mitra Clip Device Intervention
Time Frame
Through 5 years
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
6 months
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
1 year
Title
Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year
Time Frame
Baseline to 1 year
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
24 months
Title
Changes in Six Minute Walk Test (6MWT) Distance From Baseline
Time Frame
At 24 months
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
3 years
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
4 years
Title
Six Minute Walk Test (6MWT) Distance
Description
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame
5 years
Title
Number of Participants With Mitral Valve Surgery
Description
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Time Frame
30 days
Title
Number of Participants With Mitral Valve Surgery
Description
Surgical access to repair or replace the mitral valve. Measured per occurrence.
Time Frame
1 year
Title
Number of Participants With Additional AVJ-514 Device Intervention
Description
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Time Frame
30 days
Title
Number of Participants With Additional AVJ-514 Device Intervention
Description
Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.
Time Frame
1 year
Title
Number of Hospitalizations and Reason for Hospitalization
Time Frame
1 year post index procedure
Title
Number of Hospitalizations
Time Frame
24 months
Title
Number of Hospitalizations
Time Frame
3 years
Title
Number of Hospitalizations
Time Frame
4 years
Title
Number of Hospitalizations
Time Frame
5 years
Title
Number of Participants With Mitral Stenosis
Description
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time Frame
1 year
Title
Mitral Stenosis
Description
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the site.
Time Frame
24 months
Title
Mitral Stenosis
Description
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time Frame
3 years
Title
Mitral Stenosis
Description
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time Frame
4 years
Title
Mitral Stenosis
Description
Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.
Time Frame
5 years
Title
Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Description
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time Frame
12 months
Title
Number of Participants With Clinically Significant ASD That Requires Intervention
Description
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time Frame
24 months
Title
Number of Participants With Clinically Significant ASD That Requires Intervention
Description
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time Frame
3 years
Title
Number of Participants With Clinically Significant ASD That Requires Intervention
Description
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time Frame
4 years
Title
Number of Participants With Clinically Significant ASD That Requires Intervention
Description
Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)
Time Frame
5 years
Title
Number of Participants With Major Bleeding
Description
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Time Frame
30 days
Title
Number of Participants With Major Bleeding
Description
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition. Type 3: Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision
Time Frame
1 year
Title
Number of Participants With Usage of Concomitant Cardiac Medications
Description
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time Frame
At baseline (Within 14 days prior to the AVJ-514 procedure)
Title
Number of Participants With Usage of Concomitant Cardiac Medications
Description
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time Frame
30 days
Title
Number of Participants With Usage of Concomitant Cardiac Medications
Description
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time Frame
6 months
Title
Number of Participants With Usage of Concomitant Cardiac Medications
Description
Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.
Time Frame
1 year
Title
Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior
Time Frame
1 Year Pre and Post Index Procedure
Title
Number of Participants With Device Embolization Requiring Surgery
Description
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Time Frame
1 year
Title
Number of Participants With Device Embolization Not Requiring Surgery
Description
Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.
Time Frame
1 year
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
2 year
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
3 year
Title
Regurgitant Fraction (RF)
Description
Regurgitant fraction as determined by the site. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Time Frame
4 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following inclusion criteria: Age 20 years or older. Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE. Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV. Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors: Porcelain aorta or mobile ascending aortic atheroma Post-radiation mediastinum Previous mediastinitis Functional MR with LVEF < 40% Over 75 years old with LVEF < 40% Re-operation with patent grafts Two or more prior cardiothoracic surgeries Hepatic cirrhosis Other surgical risk factor(s) Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE. Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration. The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-514. If a secondary jet exists, it must be considered clinically insignificant. Transseptal catheterization and femoral vein access is determined to be feasible by the treating physician. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site. Exclusion Criteria: Subjects must not meet any of the following exclusion criteria: LVEF is < 30% Leaflet anatomy which may preclude AVJ-514 implantation, proper positioning on the leaflets or sufficient reduction in MR by the AVJ-514 based. This evaluation is based on TEE evaluation of the mitral valve within 180 days prior to subject registration and includes: Insufficient mobile leaflet available for grasping with the AVJ-514 device Lack of both primary and secondary chordal support in the grasping area Evidence of significant calcification in the grasping area Presence of a significant cleft in the grasping area Life expectancy < 1 year due to associated non-cardiac co-morbid conditions Need for emergent or urgent surgery for any reason Prior open heart mitral valve leaflet surgery or any currently implanted prosthetic mitral valve or any prior transcatheter mitral valve procedure. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated). Untreated clinically significant coronary artery disease requiring revascularization or significant myocardial ischemia or evidence of an acute myocardial infarction in the prior 90 days of registration. Cerebrovascular accident within 180 days prior to registration Severe symptomatic carotid stenosis (> 70% by ultrasound) Any cardiac surgery within 180 days prior to registration Percutaneous coronary intervention (PCI) within the last 30 days prior to registration Implant of Cardiac Resynchronization Therapy (CRT), Cardiac Resynchronization Therapy with Cardioverter Defibrillator (CRT-D) pacemaker or Implantable Cardioverter Defibrillator (ICD)within the last 30 days prior to registration. Transcatheter aortic valve replacement (TAVR) within the last 30 days prior to registration. Severe tricuspid regurgitation or aortic valve disease requiring surgical treatment. In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT). Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction drug or cardiogenic shock or intra-aortic balloon pump. History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll at least 14 days after discontinuation of antibiotics). Patients must be free from infection prior to treatment. Any required dental work should be completed a minimum of 21 days prior to treatment. Intravenous drug abuse or suspected inability to adhere to follow-up. Patients in whom TEE is contraindicated. A known hypersensitivity or contraindication to study or procedure medications which cannot be adequately managed medically. In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the test device or the placement of the test device would disrupt the leads. Subject intends to participate in any other investigational or invasive clinical study within a period of 1 year following the AVJ-514 procedure. Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials). In the opinion of the investigator or designee, subject is unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. In the opinion of the anesthesiologist, general anesthesia is contraindicated. Pregnant or planning pregnancy within next 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryohei Yozu, MD, PhD
Organizational Affiliation
Keio University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Morimasa Takayama, MD, PhD
Organizational Affiliation
Sakakibara Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Staehr, MD
Organizational Affiliation
Abbott Vascular, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Shonan Kamakura General Hospital
City
Kanagawa
Country
Japan
Facility Name
Sendai Kosei Hospital
City
Miyagi
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Osaka
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan
Facility Name
Sakakibara Heart Institute
City
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28321004
Citation
Hayashida K, Yasuda S, Matsumoto T, Amaki M, Mizuno S, Tobaru T, Jujo K, Ootomo T, Yamaguchi J, Fukuda K, Saito S, Foster E, Qasim A, Kitakaze M, Yozu R, Takayama M. AVJ-514 Trial - Baseline Characteristics and 30-Day Outcomes Following MitraClip(R) Treatment in a Japanese Cohort. Circ J. 2017 Jul 25;81(8):1116-1122. doi: 10.1253/circj.CJ-17-0115. Epub 2017 Mar 17.
Results Reference
derived

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AVJ-514 Japan Trial

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